FDA Final Guidance – Use of Standards Guidance

This final guidance, “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices,” replaces the 2013 draft guidance. This guidance focuses on clarifying and formalizing existing FDA practice including the requirement to submit FDA’s standards form for each standard used as well as discusses the use of obsolete standards. Originally standards were a focus for Abbreviated 510(k), but FDA has been requiring information on all standards mentioned in premarket submissions for several years. This guidance formalizes that practice.